Application 016931
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | R-GENE 10 | ARGININE HYDROCHLORIDE | INJECTABLE;INJECTION | 10GM/100ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-0436 | R-Gene | Arginine Hydrochloride | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0436 | R-Gene | Arginine Hydrochloride | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0436 | R-Gene | Arginine Hydrochloride | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0436 | R-Gene | Arginine Hydrochloride | Pharmacia & Upjohn Company LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 517 | SUPPL | 2010-01-26 |
| 10938 | SUPPL | 2010-01-24 |
| 13054 | SUPPL | 2003-08-15 |
| 10937 | SUPPL | 2003-08-15 |